• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Secura DR

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall Secura DR see related information
Date Posted October 21, 2010
Recall Status1 Terminated on March 15, 2012
Recall Number Z-0115-2011
Recall Event ID 55922
PMA Number P980016S114 
Product Classification Implantable cardioverter defibrillator (non-crt) - Product Code LWS
Product Medtronic Secura DR, model D224DRG, and model D234DRG not available in the U.S.. Digital Dual chamber implantable cardioverter defibrillator (DDE-DDDR). Sterilized using ethylene oxide. Medtronic, Inc., Minneapolis, MN 55432 USA. Manufactured in: Juncos, Puerto Rico, USA.
The Dual chamber implantable cardioverter defibrillator (ICD) is a multiprogrammable cardiac device that monitors and regulates the patient's heart rate by providing single or dual chamber rate-responsive bradycardia pacing, ventricular tachyarrhythmia therapies, and atrial tachyarrhythmia therapies. The device automatically detects ventricular tachyarrhythmias (VT/VF) and provides treatment with defibrillation, cardioversion, and antitachycardia pacing therapies. The device also automatically detects atrial tachyarrhythmias (AT/AF) and provides treatment with cardioversion and antitachycardia pacing therapies. The device responds to bradyarrhythmias by providing bradycardia pacing therapy.
Code Information S, PZC612421S thru PZC612482S, PZC612484S, PZC612485S, PZC612486S, PZC612487S, PZC612488S, PZC612490S thru PZC612540S, PZC612542S thru PZC612664S, PZC612666S thru PZC612688S, PZC612798S,
Recalling Firm/
Manufacturer
Medtronic Inc. Cardiac Rhythm Disease Managment
8200 Coral Sea St. N.E.
Saint Paul MN 55112
763-514-4000
For Additional Information Contact
763-514-4000
Manufacturer Reason
for Recall
Medtronic is informing you of a rare device software issue in certain ICD and CRT-D devices. A software update will be available to correct his issue. There have been 5 reports of this issue occurring with no reported patient injuries or deaths. Medtronic has identified the root cause to be a rare and specific sequence of events that must occur within a few milliseconds of each other. In the u
FDA Determined
Cause 2
Software design
Action Medtronic, Inc. sent an IMPORTANT MEDICAL DEVICE CORRECTION LETTER, dated May 2010 to physicians beginning May 05, 2010. The letter informed doctors of the issue and informed them that a software update would be available to correct this issue. The software was to be installed on the programmer, with a Medtronic representatives assistance, so that on a patient's next in-clinic interrogation the device would receive the upgrade automatically and their device would be corrected. For any questions regarding this recall physicians were to contact their local Medtronic Representative or Medtronic Technical Services at 800-723-4636.
Quantity in Commerce 41848
Distribution Worldwide Distribution - USA, Puerto Rico, Virgin Islands, and the countries of Algeria, Argentina, Australia, Austria, Bangladesh, Belgium, Brazil, Brunei Darussalam, Canada, Chile, China, Colombia, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Finland, France, Germany, Greece, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Kuwait, Latvia, Lebanon, Libya, Luxembourg, Macedonia, Malaysia, Malta, Martinique, Mexico, Morocco, Netherlands, New Zealand, Norway, Oman, Pakistan, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Saint Lucia, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, United Arab Emirates, United Kingdom, Vatican City, Venezuela, and Viet Nam.
Total Product Life Cycle TPLC Device Report

1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
PMA Database PMAs with Product Code = LWS and Original Applicant = MEDTRONIC INC.
PMAs with Product Code = LWS and Original Applicant = MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT
PMAs with Product Code = LWS and Original Applicant = MEDTRONIC VASCULAR
PMAs with Product Code = LWS and Original Applicant = MEDTRONIC, INC.
-
-